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CymaBay Therapeutics (NASDAQ:CBAY) said the FDA has expanded the breakthrough therapy designation for its drug candidate seladelpar in the treatment of primary biliary pruritus, or PBC.
CymaBay shares rose 6% in morning trading following the news.
Previously, the FDA had approved breakthrough status for seladelpar based on evidence showing that it was associated with a substantial reduction in serum alkaline phosphatase, or ALP. The revised breakthrough designation includes the treatment of PBC in adults without cirrhosis or with compensated cirrhosis.
The innovative designation allows the drug’s marketing application to be submitted to the FDA on a rolling basis, among other benefits.
Other PBC therapy developers include Genfit SA (GNFT), Ipsen (OTCPK:IPSEY), (OTCPK:IPSEF) and Intercept Pharmaceuticals (ICPT).
